Application of 18F-CP6A PET Imaging in Synucleinopathies

Launched by WUHAN UNION HOSPITAL, CHINA · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 18F-CP6A PET imaging, which aims to improve the diagnosis of certain brain diseases known as synucleinopathies. These diseases, which include Parkinson's Disease, Dementia with Lewy Bodies, and Multiple System Atrophy, are caused by the buildup of a protein called α-synuclein in the brain, leading to serious neurological problems. Currently, it can be challenging for doctors to differentiate between these conditions, but the new imaging agent may help by specifically targeting the α-synuclein deposits, potentially allowing for earlier and more accurate diagnosis.

To participate in this study, healthy volunteers aged 18-65 and patients aged 50-80 who have been diagnosed or are suspected to have one of these diseases can apply. Participants will undergo PET imaging to assess the safety and effectiveness of the 18F-CP6A agent. The study aims to gather valuable information on how this imaging can be used in clinical practice. If you or someone you know is interested in participating, it's important to discuss any medical history with your doctor to see if you meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Healthy Volunteers:
• • 1. Fully understand and voluntarily sign the informed consent form.
• • 2. Aged 18-65 years, any gender.
• • 3. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; BMI within 19.0-26.0 kg/m2.
• • 4. Non-synucleinopathy, normal motor function, UPDRS score of 0.
• • 5. No history of other neurological or chronic diseases in the last 3 years.
• • 6. No abnormal vital signs or physical examination findings.
• • 7. No pregnancy or lactation, and willing to use effective contraception during the trial period and for 6 months post-study.
• • 8. No participation in other clinical trials within the past month.
• • 9. Able to communicate effectively with the study team and understand and comply with the study requirements.
• Synucleinopathy Patients:
• • 1. Ability to sign the informed consent form or by a legal representative.
• • 2. Aged 50-80 years, any gender.
• • 3. Clinically diagnosed or suspected PD, MSA, or DLB based on diagnostic criteria \[including China's Parkinson's Disease Diagnosis (2016), MSA Consensus (2022), and DLB Guidelines (2021)\].
• • 4. No other neurological diseases, severe chronic diseases, or malignancies.
• • 5. No family history of neurodegenerative diseases or movement disorders.
• • 6. Female participants of childbearing potential must use contraception throughout the study period.
• Exclusion Criteria:
• Healthy Volunteers:
• • 1. Any severe or unstable medical condition, acute diseases prior to the study.
• • 2. Pregnant or breastfeeding women.
• • 3. Any surgery within the last 6 months that could affect drug absorption, distribution, metabolism, or excretion.
• • 4. Use of any medication (prescription or over-the-counter) within 2 weeks prior to the study.
• • 5. Inability to undergo PET/MRI or PET/CT imaging (e.g., claustrophobia).
• • 6. Participation in studies involving radioactive substances within the last 12 months.
• • 7. Any other factor that may interfere with study results.
• Synucleinopathy Patients:
• • 1. Inability or unwillingness to sign the informed consent form.
• • 2. Pregnant or breastfeeding participants.
• • 3. History of other neurological diseases or severe chronic illnesses.
• • 4. Known allergy to α-Syn imaging agents or synthetic excipients.
• • 5. Inability to complete PET/MR or PET/CT imaging.
• • 6. Researcher assesses poor compliance or other conditions that would render participation unsuitable.
• • 7. Major surgery within the last month.
• • 8. Participation in other clinical trials within the last 3 months.